Introduction of a separate group for software in the regulatory nomenclature of medical devices in Russia

The Ministry of Health has adjusted the nomenclature classification of medical devices, separating software, which is a medical device, into a separate group. The classification of software is given depending on the potential risk of its use. A potential risk class is assigned to software regardless of the potential risk class of the medical device in combination with which it is used. The order does not apply to medical products previously submitted for state registration.

The Federal Service for Surveillance in Healthcare informs that on August 10, 2020, the Ministry of Justice of the Russian Federation registered the order of the Ministry of Health of the Russian Federation dated 07.07.2020 No. 686n "On amendments to Appendices No. 1 and No. 2 to the order of the Ministry of Health of the Russian Federation dated June 6, 2012, No. 4n "On approval of the nomenclature classification of medical devices" (registration No. 59225).

This regulatory legal act provides the introduction of a separate section for the classification of software, which is a medical device, depending on the potential risk of its use, as well as a group in the nomenclature classification of medical devices by type.

Each software (medical device) can be attributed to only one class of potential risk of use:

• Class 1 - low-risk software;
• Class 2a - software with a medium degree of risk;
• Class 2b - software with an increased degree of risk;
• Class 3 - high-risk software.

The approach to the classification of software that is a medical device, depending on the potential risk of its use, presented in this order, is harmonized with the approaches described in the documents of the International Medical Device Regulatory Forum (IMDRF).

See the full details here.

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